Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

This study is ongoing, but not recruiting participants.

Study NCT00005970 Information provided by National Cancer Institute (NCI)

First Received: July 5, 2000 Last Updated: November 8, 2011 History of Changes

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Study Status:	This study is ongoing, but not recruiting participants.
Estimated Study Completion Date:	No date given
Estimated Primary Completion Date:	No date given

Publications:

Perez EA, Jenkins RB, Dueck AC, Wiktor AE, Bedroske PP, Anderson SK, Ketterling RP, Sukov WR, Kanehira K, Chen B, Geiger XJ, Andorfer CA, McCullough AE, Davidson NE, Martino S, Sledge GW, Kaufman PA, Kutteh LA, Gralow JR, Harris LN, Ingle JN, Lingle WL, Reinholz MM. C-MYC Alterations and Association With Patient Outcome in Early-Stage HER2-Positive Breast Cancer From the North Central Cancer Treatment Group N9831 Adjuvant Trastuzumab Trial. J Clin Oncol. 2011 Jan 18; [Epub ahead of print]

Perez EA, Suman VJ, Davidson NE, Gralow JR, Kaufman PA, Visscher DW, Chen B, Ingle JN, Dakhil SR, Zujewski J, Moreno-Aspitia A, Pisansky TM, Jenkins RB. Sequential Versus Concurrent Trastuzumab in Adjuvant Chemotherapy for Breast Cancer. J Clin Oncol. 2011 Oct 31; [Epub ahead of print]

Halyard MY, Pisansky TM, Dueck AC, Suman V, Pierce L, Solin L, Marks L, Davidson N, Martino S, Kaufman P, Kutteh L, Dakhil SR, Perez EA. Radiotherapy and Adjuvant Trastuzumab in Operable Breast Cancer: Tolerability and Adverse Event Data From the NCCTG Phase III Trial N9831. J Clin Oncol. 2009 Apr 6; [Epub ahead of print]

Moreno-Aspitia A, Dueck AC, Patel T: Paclitaxel-related peripheral neuropathy associated with improved outcome of patients with early stage HER2+ breast cancer who did not receive trastuzumab in the N9831 clinical trial. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-2100, 2009.

Moreno-Aspitia A, Hillman DW, Dueck AC, et al.: Baseline and recurrence levels of soluble HER2 (sHER2) in early-stage HER2-neu positive breast cancer (HER2+BC) from the NCCTG adjuvant Intergroup trial N9831. [Abstract] J Clin Oncol 27 (Suppl 15): A-539, 2009.

Moreno-Aspitia A, Dueck AC, Lingle WL, et al.: Serum HER2 (sHER2) levels in early-stage HER2 neu (+) breast cancer (HER2+BC): results from the NCCTG adjuvant Intergroup trial N9831. [Abstract] J Clin Oncol 26 (Suppl 15): A-529, 2008.

Perez EA, Reinholz MM, Dueck AC, et al.: c-MYC amplification and correlation with patient outcome in early stage HER2+ breast cancer from the NCCTG adjuvant intergroup trial N9831. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-56, 2008.

Perez EA, Suman VJ, Davidson NE, Sledge GW, Kaufman PA, Hudis CA, Martino S, Gralow JR, Dakhil SR, Ingle JN, Winer EP, Gelmon KA, Gersh BJ, Jaffe AS, Rodeheffer RJ. Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial. J Clin Oncol. 2008 Feb 4; [Epub ahead of print]

Kutteh LA, Hobday T, Jaffe A, et al.: A correlative study of cardiac biomarkers and left ventricular ejection fraction (LVEF) from N9831, a phase III randomized trial of chemotherapy and trastuzumab as adjuvant therapy for HER2-positive breast cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-579, 2007.

Reinholz MM, Jenkins RB, Hillman D, et al.: The clinical significance of polysomy 17 in the HER2+ N9831 intergroup adjuvant trastuzumab trial. [Abstract] Breast Cancer Res Treat 106 (1): A-36, S11, 2007.

Halyard MY, Pisansky TM, Solin LJ, et al.: Adjuvant radiotherapy (RT) and trastuzumab in stage I-IIA breast cancer: toxicity data from North Central Cancer Treatment Group phase III trial N9831. [Abstract] J Clin Oncol 24 (Suppl 18): A-523, 2006.

Perez EA, Suman VJ, Davidson NE, Martino S, Kaufman PA, Lingle WL, Flynn PJ, Ingle JN, Visscher D, Jenkins RB. HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial. J Clin Oncol. 2006 Jul 1;24(19):3032-8.

Miller DV, Jenkins RB, Lingle WL, et al.: Focal HER2/neu amplified clones partially account for discordance between immunohistochemistry and fluorescence in-situ hybridization results: data from NCCTG N9831 intergroup adjuvant trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-568, 19s, 2004.

Perez EA, Suman VJ, Davidson NE, et al.: HER2 testing by local, central, and reference laboratories in the NCCTG N9831 intergroup adjuvant trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-567, 19s, 2004.

Perez EA, Suman VJ, Davidson NE, Kaufman PA, Martino S, Dakhil SR, Ingle JN, Rodeheffer RJ, Gersh BJ, Jaffe AS. Effect of doxorubicin plus cyclophosphamide on left ventricular ejection fraction in patients with breast cancer in the North Central Cancer Treatment Group N9831 Intergroup Adjuvant Trial. J Clin Oncol. 2004 Sep 15;22(18):3700-4.

Perez EA, Suman VJ, Davidson NE, et al.: Effect of doxorubicin plus cyclophosphamide (AC) on left ventricular ejection fraction (LVEF) in the NCCTG N9831 intergroup adjuvant trial. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-75, 19, 2003.

Roche PC, Suman VJ, Jenkins RB, Davidson NE, Martino S, Kaufman PA, Addo FK, Murphy B, Ingle JN, Perez EA. Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst. 2002 Jun 5;94(11):855-7.